Issue on Biowaiver of Metoprolol Succinate Tablet [Regulatives / Guidelines]

posted by cra_lalit – 2010-05-28 15:12 (5874 d 17:02 ago) – Posting: # 5394
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I am currently working on a modified release (extended) Metoprolol Succinate Tablet project. Is lower strength qualify for Biowaiver? Does EMEA consider the same as per USFDA biowaiver guideline?
Please suggest me any reference documents for this and Please guide me on same.

Edit: category changed [Ohlbe]
Edit: Please see the Policy. [Helmut]

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